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Ref: 231-30-70023-B LEA MONTELUKAST 5mg TAB TUK Version: 2 3 January 2013
PL Number(s), PL 00289/1118. TEVA UK Limited Licence. MA Holder & Packer: Packed at Teva UK Limited, Eastbourne. Packing Line TBC.
	TEVA UK LIMITED
Reason for revision: B Revision: Update to Text from Reg to Version 8d1. Inconsistency in reg text (change from two = 2 3rd section 3rd para). V2: Update to cutter guide (10 mm around all edges).

Colours:

(PANTONE® is a registered trademark of Pantone, Inc.)

PANTONE® GREEN C

PAGE 1: FRONT FACE (INSIDE OF REEL)

MONTELUKAST 5 mg CHEWABLE TABLETS For children 6 to 14 years of age

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking

this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1.    What Montelukast Chewable Tablets are and what they are used for

2.    Before you take Montelukast Chewable Tablets

3.    How to take Montelukast Chewable Tablets

4.    Possible side effects

5.    How to store Montelukast Chewable Tablets

6.    Further information

OWHAT MONTELUKAST CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR

Montelukast Chewable Tablets are a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast Chewable Tablets improve asthma symptoms and help control asthma.

Your doctor has prescribed Montelukast Chewable Tablets to treat your child's asthma, preventing asthma symptoms during day and night.

Montelukast Chewable Tablets are used for the treatment of patients 6 to 14 years of age who are not adequately controlled on their asthma medications and need additional therapy.

Montelukast Chewable Tablets may also be used as an alternative treatment to inhaled corticosteroids for 6 to 14 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids.

Montelukast Chewable Tablets, in patients 6 to 14 years of age, also helps prevent asthma symptoms which are triggered by exercise.

Your doctor will determine how Montelukast Chewable Tablets should be used depending on the symptoms and severity of your child's asthma.

What is asthma?

Asthma is a long-term disease.

Asthma includes:

•    difficulty breathing because of narrowed airways. This narrowing of airways worsens and improves in response to various conditions.

•    sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.

•    swelling (inflammation) in the lining of the airways.

Symptoms of asthma include: Coughing, wheezing, and

chest tightness.

It is important that your child uses all the asthma medication prescribed by the doctor as intended. Montelukast Chewable Tablets should not replace steroid medications (whether inhaled or taken by mouth) that your child may already be using.

If your child has phenylketonuria you should note that Montelukast Chewable Tablets contain aspartame, which is a source of phenylalanine. The phenylalanine in the tablets may be harmful to people with phenylketonuria.

A rare condition has been seen in a very small number of patients taking asthma medications, including montelukast. If you experience a combination of any of the following symptoms, particularly if they are persistent and worsening, seek medical attention immediately: flu-like illness, increasing breathlessness, pins and needles or numbness of limbs, and/or rash.

Use in infants and toddlers: Montelukast Chewable Tablets are not recommended for use in children under two years of age.

Taking other medicines

Montelukast Chewable Tablets may be used together with other medicines your child may be taking for asthma. However, some medicines can interfere with Montelukast Chewable Tablets, or Montelukast Chewable Tablets may affect how your child's other medicines work.

Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including those medicines obtained without a prescription. This is particularly important if the other medicine is:

•    phenobarbital (used for treatment of epilepsy)

•    phenytoin (used for treatment of epilepsy)

•    rifampicin (used to treat tuberculosis and some other infections).

Taking Montelukast Chewable Tablets with food and drink

If Montelukast Chewable tablets are taken together with food they should be taken in the evening 1 hour before or 2 hours after food.

Pregnancy and breast-feeding

Pregnancy: Female patients who are pregnant, intend to become pregnant or think they might be pregnant should consult their doctor before taking Montelukast Chewable Tablets.

Breast-feeding: It is not known whether Montelukast Chewable Tablets is present in human breast-milk. The doctor should be consulted before Montelukast Chewable Tablets are taken, if you are already breast-feeding or intending to breast-feed a baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

In adults, Montelukast Chewable Tablets are not expected to affect their ability to drive a car or operate machinery. However, individual responses to medication may vary. Certain side effects that have been reported very rarely with Montelukast Chewable Tablets may affect some patients' ability to drive or operate machinery.

Important information about some of the ingredients of Montelukast Chewable Tablets:

Montelukast Chewable Tablets contain aspartame, a source of phenylalanine. May be harmful for people with phenylketonuria

©BEFORE YOU TAKE MONTELUKAST CHEWABLE TABLETS

Do not use Montelukast Chewable Tablets if:

• your child is allergic (hypersensitive) to montelukast sodium or any of the other ingredients of Montelukast Chewable Tablets.

Take special care with Montelukast Chewable Tablets

•    Oral Montelukast Chewable Tablets is NOT intended for the treatment of a sudden attack of breathlessness. It will not help your child in this situation and should never be used for this purpose. If an attack occurs, the instructions that the doctor has given should be followed exactly. It is very important to have the medication needed for such an attack readily accessible at all times.

•    If your child needs to use their beta-agonist inhaler more often than usual, you should consult your child's doctor as soon as possible.

©HOW TO TAKE MONTELUKAST CHEWABLE TABLETS

Ensure that your child always takes Montelukast Chewable Tablets as instructed by your doctor, even when your child has no symptoms, or if your child experiences an asthma attack. You should check with your doctor or pharmacist if you are not sure.

The usual dose for children aged 6 to 14 years is one Montelukast 5 mg Chewable Tablet daily in the evening.

If Montelukast Chewable Tablets use is associated with food, the tablets should be taken 1 hour before or 2 hours after food.

Montelukast Chewable Tablets should not be used together with other products that contain the same active ingredient, montelukast.

Ref: 231-30-70023-B LEA MONTELUKAST 5mg TAB TUK Version: 2 3 January 2013	hr1 =17.1
PL Number(s), PL 00289/1118. TEVA UK Limited Licence. MA Holder & Packer: Packed at Teva UK Limited, Eastbourne. Packing Line TBC.
	TEVA UK LIMITED
Reason for revision: B Revision: Update to Text from Reg to Version 8d1. Inconsistency in reg text (change from two = 2 3rd section 3rd para). V2: Update to cutter guide (10 mm around all edges).

Colours:

(PANTONE® is a registered trademark of Pantone, Inc.)

PANTONE® GREEN C

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you take more Montelukast Chewable Tablets than you should

If your child (or someone else) swallows a lot of the tablets all together, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause abdominal pain, sleepiness, thirst, headache, vomiting, and involuntary movement. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Montelukast Chewable Tablets

If your child misses a dose, just carry on with the next one as usual. Do not take or give a double dose to make up for a forgotten dose.

If your child stops taking Montelukast Chewable Tablets It is important to continue taking Montelukast Chewable Tablets in the presence or absence of symptoms, for as long as your child's doctor prescribes it, in order to help maintain control of your child's asthma. Montelukast Chewable Tablets can help control your asthma only with continued use.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Montelukast Chewable Tablets can cause side effects, although not everybody gets them.

In clinical studies with Montelukast 5 mg chewable tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to montelukast were:

•    headache

Additionally, the following side effects were reported in clinical studies with montelukast 4 mg chewable tablets and 10 mg film-coated tablets:

•    abdominal pain

•    thirst

These were usually mild and occurred at a greater frequency in patients treated with montelukast than placebo (a pill containing no medication).

The frequency of possible side effects listed below is defined using the following convention:

Very common (affects at least 1 user in 10)

Common (affects 1 to 10 users in 100)

Uncommon (affects 1 to 10 users in 1,000)

Rare (affects 1 to 10 users in 10,000)

Very rare (affects less than 1 user in 10,000)

Additionally, while the medicine has been on the market, the following has been reported:

Very common (affects at least 1 user in 10)

•    upper respiratory infection

Common (affects 1 to 10 users in 100)

•    diarrhoea, nausea, vomiting

•    fever

•    rash

•    elevated liver enzymes

Rare (affects 1 to 10 users in 10,000)

•    increased bleeding tendency

•    tremor

•    palpitations

•    swelling beneath the skin

Very rare (affects less than 1 user in 10,000)

•    hallucinations, disorientation, suicidal thoughts and actions

•    hepatitis (inflammation of the liver)

•    tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning

•    hepatic eosininophilic infiltration.

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported. You must tell your doctor right away if you get one or more of these symptoms.

Ask your doctor or pharmacist for more information about side effects.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

©HOW TO STORE MONTELUKAST CHEWABLE TABLETS

Keep out of the reach and sight of children.

Do not store above 30°C. Keep blister in the outer carton in order to protect from light.

Do not use Montelukast Chewable Tablets after the expiry date that is stated on the blister and carton. The expiry date refers to the last day of that month

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

^ FURTHER INFORMATION

What Montelukast Chewable Tablets contain:

•    the active ingredient is montelukast sodium equivalent to 5 mg montelukast

•    the other ingredients include: mannitol (E421), sodium laurilsulfate, hydroxypropyl cellulose, Red iron oxide (E172), Flav.cherry PHS-143671: maltodextrins (maize) and starch modified E1450 (Waxy maize), aspartame (E951), sodium starch glycolate Type A, magnesium stearate

What Montelukast Chewable Tablets looks like and contents of the pack

Montelukast 5 mg Chewable Tablets are mottled pink, square shaped tablet, debossed with "93" on one side and "7425" on the other side of the tablet.

Montelukast 5 mg Chewable Tablets are available in packs of 7, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets and calendar packs of 7, 14, 28, 56 and 98 tablets.

Uncommon (affects 1 to 10 users in 1,000)

•    allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing

•    behaviour and mood related changes [dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression

•    dizziness, drowsiness, pins and needles/numbness, seizure

•    nosebleed

•    dry mouth, indigestion

•    bruising, itching, hives

•    joint or muscle pain, muscle cramps

•    tiredness, feeling unwell, swelling

Aluminium - Aluminium blister packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom.

This leaflet was last revised in August 2012

PL 00289/1118

‘iZHZD

TEVA UK LIMITED 70023-B